REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System

NCT02854319 | Terminated DMC

• 1 other identifier: S2367
• Study Type: interventional
• Target: 15
• Locations: 3 countries
• Sites: 3

Brief Summary

The objective of the REPRISE EDGE study is to confirm the acute performance and safety of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set for transcatheter aortic valve implantation (TAVI) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Mean aortic valve pressure gradient

  Mean aortic valve pressure gradient as measured by echocardiography and assessed by an independent core laboratory.

  At discharge from hospital or at 7 days post-procedure (whichever comes first)

Secondary Outcomes (5)

• Technical success

  Immediately post-procedure (patient discharged from operative room)

• Effective orifice area

  At discharge from hospital or at 7 days post-procedure (whichever comes first)

• Successful repositioning of the study valve if repositioning is attempted

  Immediately post-procedure (patient discharged from operative room)

• Successful retrieval of the study valve if retrieval is attempted

  Immediately post-procedure (patient discharged from operative room)

• Grade of paravalvular aortic regurgitation

  At discharge from hospital or at 7 days post-procedure (whichever comes first)

Other Outcomes (26)

• Mortality: all-cause, cardiovascular, and non-cardiovascular

  At discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1 year post procedure

• Stroke: disabling and non-disabling

  At discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1 year post procedure

• Myocardial infarction (MI): periprocedural (≤72 hours post index procedure) and spontaneous (>72 hours post index procedure)

  At discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1 year post procedure

Study Arms (1)

LOTUS Edge Valve System

EXPERIMENTAL

Transcatheter aortic valve implantation (TAVI) with the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set

Device: LOTUS Edge Valve System

Interventions

LOTUS Edge Valve System DEVICE

Transcatheter Aortic Valve Implantation (TAVI) with the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set

LOTUS Edge Valve System

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Subject is ≥70 years of age.
• Subject has documented calcific native aortic valve stenosis with an initial aortic valve area (AVA) of \<1.0 cm2 (or AVA index of \<0.6 cm2/m2) and either a mean pressure gradient \>40 mm Hg or a jet velocity \>4 m/s, as measured by echocardiography and/or invasive hemodynamics.
• Note: In cases of low flow, low gradient aortic stenosis dobutamine can be used to assess the grade of aortic stenosis (maximum dobutamine dose of 20 mcg/kg/min recommended)c; the subject may be enrolled if echocardiographic criteria are met with this augmentation.
• Subject has a documented aortic annulus size between ≥20 mm and ≤27 mm based on pre-procedure diagnostic imaging.
• Subject has symptomatic aortic valve stenosis with NYHA Functional Class ≥ II.
• Subject is considered high risk for surgical valve replacement based on at least one of the following:
• STS score ≥8%, and/or
• Agreement by the heart team (which must include an in-person evaluation by an experienced cardiac surgeon) that subject is at high operative risk of serious morbidity or mortality with surgical valve replacement.
• Heart team (which must include an experienced cardiac surgeon) assessment that the subject is likely to benefit from valve replacement
• Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.
• Subject, family member and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits.

You may not qualify if:

• Subject has a congenital unicuspid or bicuspid aortic valve.
• Subject with an acute myocardial infarction within 30 days of the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin level elevation).
• Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months, or has any permanent neurologic defect prior to study enrollment.
• Subject is on dialysis or has serum creatinine level \>3.0 mg/dL or 265 µml/L.
• Subject has a pre-existing prosthetic aortic or mitral valve.
• Subject has \>3+ mitral regurgitation, \>3+ aortic regurgitation or \>3+ tricuspid regurgitation.
• Subject has a need for emergency surgery for any reason.
• Subject has a history of endocarditis within 12 months of index procedure or evidence of an active systemic infection or sepsis.
• Subject has echocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention.
• Subject has Hgb \<9 g/dL, platelet count \<50,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<1,000 cells/mm3.
• Subject requires chronic anticoagulation therapy after the implant procedure and cannot be treated with warfarin (other anticoagulants are not permitted in the first month) for at least 1 month concomitant with either aspirin or clopidogrel.
• Note: An alternative P2Y12 inhibitor may be prescribed if subject is allergic to or intolerant of clopidogrel
• Subject has had a gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months, or has other clinically significant bleeding diathesis or coagulopathy that would preclude treatment with required antiplatelet regimen, or will refuse transfusions.
• Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all thienopyridines, heparin, nickel, titanium, or polyurethanes.
• Subject has a life expectancy of less than 12 months due to non-cardiac, co-morbid conditions based on the assessment of the investigator at the time of enrollment.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (3)

Rigshospitalet

Copenhagen, Denmark

Location

Clinique Pasteur

Toulouse, France

Location

Skåne University Hospital

Lund, Sweden

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Matthias Götberg, MD, PhD

  Skane University Hospital

  PRINCIPAL INVESTIGATOR

• Sabine Bleiziffer, MD

  German Heart Centre München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 3, 2016
• Study Start: September 7, 2016
• Primary Completion: October 25, 2016
• Study Completion: March 13, 2018
• Last Updated: May 31, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); SE (1); DK (1)